Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2014 Jun;4(3):159-165.
doi: 10.1016/j.jpha.2013.09.003. Epub 2013 Sep 17.

Development of forced degradation and stability indicating studies of drugs-A review

M Blessy  1 , Ruchi D Patel  1 , Prajesh N Prajapati  1 , Y K Agrawal  1
Affiliations
Review

Development of forced degradation and stability indicating studies of drugs-A review

M Blessy et al. J Pharm Anal. 2014 Jun.

Abstract

Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. In addition, the regulatory guidance is very general and does not explain about the performance of forced degradation studies. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms and also describes the analytical methods helpful for development of stability indicating method.

Keywords: Degradation conditions; Degradation product; Forced degradation; Stability indicating method; Stress testing.

PubMed Disclaimer

Figures

Scheme 1
Scheme 1
An illustrative flowchart describing various stress conditions used for degradation of drug substance and drug product.
None
See this image and copyright information in PMC

References

    1. ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision 2), International Conference on Harmonization. Available from: 〈http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128204...., 2003.
    1. Reynolds D.W., Facchine K.L., Mullaney J.F. Available guidance and best practices for conducting forced degradation studies. Pharm. Technol. 2002;26(2):48–56.
    1. Brummer H. How to approach a forced degradation study. Life Sci. Technol. Bull. 2011;31:1–4.
    1. FDA Guidance for Industry, INDs for Phase II and III Studies—Chemistry, Manufacturing, and Controls Information, Food and Drug Administration. Available from: 〈http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat..., 2003.
    1. FDA Guidance for Industry, INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Draft Guidance, Food and Drug Administration. Available from: 〈http://www.fda.gov/ohrms/dockets/98fr/990674gd.pdf〉, 1999.